Intravenous and gavage therapy are often prescribed in hospitals for infants diagnosed with serious illnesses. In the former procedure, a tunneled central catheter, which is connected to a volumetric pump and a bottle or bag via an intravenous line or tubing, is infused into an infant's superior vena cava or subclavial vein for delivering into the infant various pharmaceutical fluids via the infused line or tubing. This type of invasive therapy generally includes, inter alia, hyperalimentation, hydration and antimicrobial therapy. In the latter procedure, a gastrostomy tube is inserted into an infant's stomach via the skin for feeding of the infant through the tubing. Due to the foreign nature and placement of the line infused into the infant, the infant may intentionally or inadvertently disconnect the line with his hands or mouth by pulling on, splitting or biting it.
In the past, in order to prevent infants from dislodging infused lines, the infants' limbs were manually or mechanically restrained in some manner. When the infants' limbs were restrained manually, this proved to be inconvenient to the attendants administering or monitoring the invasive therapy. This also would sometimes interfere with and delay the administration of emergency care vitally needed by critically ill infants. When the infants' limbs were restrained mechanically, this was accomplished by, for instance, taping their hands to objects, such as mattresses, which proved to be restrictive and uncomfortable to the infants. Mechanical restraint was also accomplished by mechanical restraining devices, as exemplified in U.S. Pat. No. 3,920,012, which prevented free movement of the infants' arms. Regardless of whether the infants were restrained manually or mechanically, such restraints in both cases prevented the infants from engaging in free movement, interferred with mental health and development and discouraged play.
In view of the disadvantages associated with present methods and devices for preventing infants from removing or dislodging intentionally or inadvertently infused lines associated with invasive therapy, there is a definite need to develop means which prevent infants from removing or dislodging such infused lines without interferring with the infants' free movement or play, which are comfortable to the infants, which do not inconvenience attendants administering or monitoring the invasive therapy and which do not interfere with or delay the administration of such therapy.